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Russian Pharmaceutical Technologies is developing RPT835, an allosteric inhibitor of fibroblast growth factor receptor 2 (FGFR2) for the treatment of FGFR2-expressing tumors. RPT835 has shown potent inhibition of FGF signaling, angiogenesis, and cancer growth in preclinical studies. The company plans to begin a Phase I/II clinical trial of RPT835 in February 2015 in patients with FGFR2-expressing cancers like gastric, breast, endometrial, colorectal, and renal cell carcinoma. If successful, the company will conduct a Phase III trial in 2018 and seek accelerated approval in Russia and other countries.
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Pharmacogenomics is the study of how genetic variations affect individual responses to drugs. It examines genomic loci and biological pathways to determine variability in drug metabolism and effects. Pharmacogenetics focuses on clinical effects of single gene variants. Pharmacogenomics can improve drug safety, efficacy and discovery by tailoring treatments based on a person's genetics. It allows optimization of drug metabolism and dosing based on an individual's genetic profile. Variations in genes that encode drug targets, metabolizing enzymes, transporters and those associated with adverse drug reactions can impact drug responses. Pharmacogenomics aims to incorporate genetic insights to develop safer and more effective precision medicines.
Panitumumab (vectibix)
Panitumumab is a fully human monoclonal antibody that binds to the epidermal growth factor receptor (EGFR) with high affinity. It is approved as monotherapy or in combination with chemotherapy for wild-type KRAS metastatic colorectal cancer. Clinical trials have shown that panitumumab improves progression-free survival and overall survival when added to chemotherapy for first-line treatment of metastatic colorectal cancer patients with wild-type RAS tumors. Extended RAS testing beyond just KRAS exon 2 is important to identify patients most likely to benefit from panitumumab therapy. Common side effects include dermatological toxicities.
Pharmacogenetics
Pharmacogenetics is the study of how genetic factors influence individual responses to drugs. Variations in genes involved in drug metabolism and response can help explain differences in drug efficacy and toxicity between individuals. Understanding these genetic factors may allow doctors to personalize drug selection and dosing for each patient, improving outcomes by decreasing adverse reactions and increasing efficacy. However, concerns remain regarding the reliability of pharmacogenetic tests, healthcare providers' preparedness to apply this information, and potential issues around discrimination and privacy with a personalized medicine approach.
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MHY2013 is a novel PPAR pan-agonist that was shown to have beneficial effects on metabolic disorders in mouse models of obesity and diabetes. It activated all PPAR subtypes and increased fatty acid oxidation and energy expenditure in liver, adipose tissue, and skeletal muscle by upregulating genes involved in these pathways. MHY2013 improved insulin sensitivity, lowered blood triglycerides and fatty acids, and reduced hepatic steatosis in obese mice without affecting food intake or body weight. The compound's metabolic effects were mediated through increased levels of the hormones FGF21 and adiponectin.Pharmacogenomics
A brief material on pharmacogenomics, polymorphisms, mutations, personalized medicine, its applications, benefits and limitations
cocogenetics.pdf
This document provides an overview of pharmacogenomics. It defines pharmacogenomics as the study of how an individual's genetic inheritance affects their response to drugs. It discusses how genetic variants like mutations and single nucleotide polymorphisms can influence drug efficacy and toxicity based on variations in drug-metabolizing enzymes and receptors. The document also outlines some of the potential benefits of personalized medicine based on pharmacogenomic insights, as well as some limitations to its implementation in clinical practice.
G- Protein Coupled Receptors
GPCRs are the most dynamic and most abundant all the receptors. The G protein-coupled receptor (GPCR) superfamily comprises the largest and most diverse group of proteins in mammals. GPCRs are responsible for every aspect of human biology from vision, taste, sense of smell, sympathetic and parasympathetic nervous functions, metabolism, and immune regulation to reproduction. GPCRs interact with a number of ligands ranging from photons, ions, amino acids, odorants, pheromones, eicosanoids, neurotransmitters, peptides, proteins, and hormones.
Nevertheless, for the majority of GPCRs, the identity of their natural ligands is still unknown, hence remain orphan receptors.
The simple dogma that underpins much of our current understanding of GPCRs, namely,
one GPCR gene− one GPCR protein− one functional GPCR− one G protein −one response
is showing distinct signs of wear.
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презентация англ.(1)
- 1. 2014
- 3. Russian Pharmaceutical Technologies is a research and development company focused on transforming innovative scientific discoveries into novel therapeutic agents. Brief company description City and country: Saint-Petersburg, Russian Federation Date of foundation: 12 April 2012 Residence status: Skolkovo Foundation Resident, Moscow Team: Russian and World experts in oncology and drug development Brief product description Product: RPT835, allosteric inhibitor of fibroblast growth factor receptor 2 Indication: FGFR2-expressing tumors Stage of development: Late-preclinical studies Expected date of Phase I/II clinical study: February 2015 Overview
- 4. Fibroblast Growth Factor Receptor 2 as a target for RPT835 The recent identification of fibroblast growth factor receptor 2 (FGFR2) overexpression or mutations in different cancer types has generated an opportunity for a novel target-based therapy Advanced cancer Efficacy of standard therapy FGFR2 Gastric cancer Poor efficacy and poor overall survival No approved targeted therapy except trastuzumab in HER2-positive patients 5-7%, amplification poor prognostic factor Triple-negative breast cancer Poor efficacy and poor overall survival No approved targeted therapy 4%, amplification poor prognostic factor Endometrial cancer Poor efficacy and poor overall survival No approved targeted therapy 10%, amplification poor prognostic factor Colorectal cancer Poor efficacy of second-line treatment Poor overall survival 3-25%, amplification poor prognostic factor Papillary renal cell carcinoma Poor efficacy and poor overall survival No approved targeted therapy 5%, overexpression Other tumors Resistance to targeted therapy Poor overall survival 1-50%
- 5. RPT835 is one of the first allosteric inhibitors in oncology Allosteric inhibitors decrease activity of receptor by binding an allosteric site at the receptor (that is, a site other than the receptor's active site). There are no approved allosteric targeted agents in oncology. RPT835 is a low-molecular weight allosteric inhibitor of FGFR2. Principle benefits of allosteric inhibitors High specificity | Low toxicity Cells with mutations sensitive to treatment Different isoforms of receptor could be targeted RPT835 inhibitor binds to allosteric site of extracellular part of FGFR2 and changes the conformation of receptor
- 6. Characterisation and comparison of RPT835 RPT835 Brivanib Bevacizumab Molecular weight 413.4 g/mol 441.5 g/mol 149 kDa IC50, FGFR2 kinase 10 nmol/L 125 nmol/L - IC50, Phospho-FGFR2 11 nmol/L 289 nmol/L - Specificity FGFR2 only VEGFR1-3, FGFR1-3 VEGF Effective dose1 for inhibition: FGF-stimulated angiogenesis VEGF-stimulated angiogenesis 15 mg/kg NA 50 mg/kg 4 mg/kg NA 10 mg/kg Route of administration Orally Orally Intravenous Brivanib , a tyrosine kinase inhibitor in clinical studies Bevacizumab, approved anti-VEGF monoclonal antibody 1Dose for significant inhibition of angiogenic effects in comparison with control The preclinical data obtained with RPT835 are consistent with potent inhibition of FGF signaling, angiogenesis, and cancer growth.
- 7. Development plan 2014 2015 2016 2017 Phase I/II study 2018 Patients with FGFR2- expressing tumors Late-stage preclinical studies Phase III randomized study Patients with FGFR2-expressing tumors Application for accelerated approval, Russia & C.I.S. Conclusions and Final approval Market
- 8. Russian Pharmaceutical Technologies LLC Griboyedov Canal nab., 130 off. 202 190121 Saint-Petersburg, Russia tel. +78129372965 office@ruspharm.com www.ruspharm.com